Simone B Schmidt1, Willibald Kulig2, Ralph Winter3, Antje S Vasold4, Anette E Knoll5, Jens D Rollnik6. 1. Institute for Neurorehabilitation Research (InFo), BDH-Clinic Hessisch Oldendorf, Hannover Medical School, Hessisch Oldendorf, Germany. Electronic address: si.schmidt@nkho.de. 2. HiPP GmbH & Co. Vertrieb KG, Georg-Hipp-Straße 7, 85276 Pfaffenhofen, Germany. 3. SRH Kurpfalzkrankenhaus Heidelberg gGmbH, Germany. 4. Medizinische Einrichtung des Bezirkes Oberpfalz KU, Klinik für Neurologische Rehabilitation, Germany. 5. AK Statistics, Kreppe 2, 85276 Pfaffenhofen, Germany. 6. Institute for Neurorehabilitation Research (InFo), BDH-Clinic Hessisch Oldendorf, Hannover Medical School, Hessisch Oldendorf, Germany.
Abstract
BACKGROUND & AIMS: Diarrhea has negative consequences for patients, health care staff and health care costs when neurological patients are fed enterally over long periods. We examined the effect of tube feeding with natural foods in reducing the number of fluid stool evacuations and diarrhea in critically ill neurological patients. METHODS: A multicenter, prospective, open-label and randomized controlled trial (RCT) was conducted at facilities in Germany specializing in early rehabilitation after neurological damage. Patients of the INTERVENTION group were fed by tube using a commercially available product based on real foods such as milk, meat, carrots, whereas CONTROL patients received a standard tube-feed made of powdered raw materials. All received enteral nutrition over a maximum of 30 days. The number of defecations and the consistency of each stool according to the Bristol Stool Chart (BSC) were monitored. In addition, daily calories, liquids and antibiotic-use were recorded. RESULTS:118 Patients who had suffered ischemic stroke, intracerebral hemorrhage, traumatic brain injury or hypoxic brain damage and requiring enteral nutrition were enrolled; 59 were randomized to receive the intervention and 59 control feed. There were no significant differences in clinical screening data, age, sex, observation period or days under enteral nutrition between the groups. Patients in both groups received equivalent amount of calories and fluids. In both groups antibiotics were frequently prescribed (69.5% in the INTERVENTION group and 75.7% in the CONTROL group) for 10-11 days on average. In comparison to the CONTROL group, patients in the INTERVENTION group had a significant reduction of the number of watery stool evacuations (type 7 BSC) (minus 61%, IRR = 0.39, p < 0.001). Further statistical evaluations using the following corrections: major diarrhea-associated confounders (number and duration of antibiotics); shorter observation period of 15 days; excluding patients with Clostridium difficile associated diarrhea (CDAD) and the Per Protocol Population, confirmed the primary hypothesis. The number of days with diarrhea was significantly lower in the INTERVENTION group (0.8 ± 1.60 days versus 2.0 ± 3.46 days). CONCLUSIONS: Tube feeding with natural based food was effective in reducing the number of watery defecations and diarrhea in long term tube-fed critically ill neurological patients, compared to those fed with standard tube feeding.
RCT Entities:
BACKGROUND & AIMS:Diarrhea has negative consequences for patients, health care staff and health care costs when neurological patients are fed enterally over long periods. We examined the effect of tube feeding with natural foods in reducing the number of fluid stool evacuations and diarrhea in critically ill neurologicalpatients. METHODS: A multicenter, prospective, open-label and randomized controlled trial (RCT) was conducted at facilities in Germany specializing in early rehabilitation after neurological damage. Patients of the INTERVENTION group were fed by tube using a commercially available product based on real foods such as milk, meat, carrots, whereas CONTROL patients received a standard tube-feed made of powdered raw materials. All received enteral nutrition over a maximum of 30 days. The number of defecations and the consistency of each stool according to the Bristol Stool Chart (BSC) were monitored. In addition, daily calories, liquids and antibiotic-use were recorded. RESULTS: 118 Patients who had suffered ischemic stroke, intracerebral hemorrhage, traumatic brain injury or hypoxic brain damage and requiring enteral nutrition were enrolled; 59 were randomized to receive the intervention and 59 control feed. There were no significant differences in clinical screening data, age, sex, observation period or days under enteral nutrition between the groups. Patients in both groups received equivalent amount of calories and fluids. In both groups antibiotics were frequently prescribed (69.5% in the INTERVENTION group and 75.7% in the CONTROL group) for 10-11 days on average. In comparison to the CONTROL group, patients in the INTERVENTION group had a significant reduction of the number of watery stool evacuations (type 7 BSC) (minus 61%, IRR = 0.39, p < 0.001). Further statistical evaluations using the following corrections: major diarrhea-associated confounders (number and duration of antibiotics); shorter observation period of 15 days; excluding patients with Clostridium difficile associated diarrhea (CDAD) and the Per Protocol Population, confirmed the primary hypothesis. The number of days with diarrhea was significantly lower in the INTERVENTION group (0.8 ± 1.60 days versus 2.0 ± 3.46 days). CONCLUSIONS: Tube feeding with natural based food was effective in reducing the number of watery defecations and diarrhea in long term tube-fed critically ill neurologicalpatients, compared to those fed with standard tube feeding.
Authors: Amy Y Spurlock; Teresa W Johnson; Ali Pritchett; Leah Pierce; Jenna Hussey; Kelly Johnson; Holly Carter; Stephen L Davidson; Manpreet S Mundi; Lisa Epp; Ryan T Hurt Journal: Nutr Clin Pract Date: 2021-08-31 Impact factor: 3.204